Prophylactic Antibiotic After Perineal Tear

NCT04763486 — Not applicable, Unknown, 2500 participants, Meir Medical Center

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Prophylactic Antibiotic Treatment for Perineal Tear After Delivery: a Randomized Controlled Trial

Registry	NCT04763486, acronym PATPET
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	2500 (Estimated)
Sponsor	Meir Medical Center (Other)
Conditions	Puerperal Infection
Interventions	Cefazolin (Cefamezin) (Drug)
Dates	start 2021-03-01 (estimated), primary completion 2022-03-01 (estimated), completion 2023-03-01 (estimated), first posted 2021-02-21, last updated 2021-02-23
Locations	1 site in Israel

-Summary

Current World Health Organization guidelines recommend routine antibiotic prophylaxis for women with perineal tear 3rd and 4th degree but not for 2nd degree because of insufficient evidence of effectiveness. The investigators aimed to investigate whether antibiotic prophylaxis prevented maternal infection after the first and second perineal tear after vaginal birth.

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+Detailed description

The PATPET trial is a randomized, controlled trial done at tertiary hospital obstetric units in Israel. Women who had first and second-degree tear (or after episiotomy) after delivery at 37 weeks or greater gestation, with no indication for ongoing prescription of antibiotics in the post-partum period and no contraindications to prophylactic Cefamezin (cefazolin), were randomly assigned (1:1) to receive a single intravenous dose of prophylactic antibiotic or not.

+Arms and interventions

Arm	Type	Interventions	Description
Prophylactic antibiotic treatment	Experimental	Drug: Cefazolin (Cefamezin)	Will be given Cefamezin antibiotic within 6 hours of delivery
No intervention	No intervention		Will not get antibiotic prophylactics

Cefazolin (Cefamezin) (Drug): Cefamezin 2 gr within 6 hour of delivery

+Outcome measures

Primary outcomes

Number of participants with a fever after delivery [6 weeks of delivery]: Maternal fever above 38 C (Celsius)

Secondary outcomes

Way of delivery [6 weeks of delivery]: Type of delivery- vacuum-assisted delivery vs. vaginally

+Eligibility

Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers

Inclusion Criteria:

* age 18-45
* perineal tear 2nd and 1st degree( episiotomy)

Exclusion Criteria:

* 3rd and 4 th degree perineal tear
* antibiotic indication during delivery
* cesarian section delivery

+Locations (1)

Facility	City	Country	Status
Meir Medical Center	Kfar Saba	Israel

+Investigators

Gil Shechter, Dr, Principal investigator, Meir Medical Center , Tel Aviv University

My Notes

Public

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